Vision Monitor- MonCvONE
K-Number: K212936 · 2022-11-21
ApplicantMetrovision
Decision Date2022-11-21
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Vision Monitor- MonCvONE is a medical device manufactured by Metrovision. It received FDA 510(k) clearance on 2022-11-21 under approval number K212936. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vision Monitor- MonCvONE?
Vision Monitor- MonCvONE is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Metrovision. The 510(k) number is K212936.
When was Vision Monitor- MonCvONE approved by the FDA?
Vision Monitor- MonCvONE received FDA 510(k) clearance on 2022-11-21, under approval number K212936.
What company makes Vision Monitor- MonCvONE?
Vision Monitor- MonCvONE is manufactured by Metrovision.
What is the FDA product code for Vision Monitor- MonCvONE?
The FDA product code for Vision Monitor- MonCvONE is GWE.
Related Clinical Trials
Other Devices by Metrovision
Related Devices (Code: GWE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.